Amines, N-(3-aminopropyl)-N'-C12-18-alkyltrimethylenedi-, reaction products with N-C12-18-alkyltrimethylenediamines and formic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1998-03-03 to 1998-03-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amines, tallow alkyl[3-(tetrahydropyrimidinyl)propyl]

EC Number:

296-557-4

EC Name:

Amines, tallow alkyl[3-(tetrahydropyrimidinyl)propyl]

Cas Number:

92797-22-3

IUPAC Name:

92797-22-3

Constituent 2

Reference substance name:

Amines, suifalkyl [(tetrahydropyrimidinyl)3-propyl]

IUPAC Name:

Amines, suifalkyl [(tetrahydropyrimidinyl)3-propyl]

Details on test material:

- Name of test material (as cited in study report): POLYRAM L200
- Chemical name : Amines, suifalkyl [(tetrahydropyrimidinyl)3-propyl]
- CAS number : 92797-22-3
- Physical state: light brown liquid
- Analytical purity: > 95 % expressed in amines content
- Purity test date: 13.02.1998
- Lot/batch No.: 96105707
- Expiration date of the lot/batch: January 1999
- Storage condition of test material: at room temperature in the dark
No other data available.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France.
- Age at study initiation: not reported
- Weight at study initiation: 2.9 kg.
- Housing: singly, in a polystyrene cage.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days before the beginning of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 30 to 70 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: each animal served as its own control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100 %

VEHICLE
- no vehicle

Duration of treatment / exposure:

3 minutes

Observation period:

1hour, 24, 48 and 72 hours after patch removal then daily until day 15.

Number of animals:

1

Details on study design:

TEST SITE
- Area of exposure: flank, clipped 24 h before exposure and checked for healthy, intact skin before application
- % coverage: 6 cm²
- Type of wrap if used: dry gauze pad held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test substance was wiped off by means of a dry gauze pad
- Time after start of exposure: 3 minutes

SCORING SYSTEM:
Dermal irritation was evaluated for each animal according to OECD guideline 404 (draize scoring system)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

(for 3 minute-exposure)

Basis:

animal #1

Time point:

other: mean of the 24, 48 and 72-hour readings

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 15 days

Remarks on result:

other: cutaneous necrosis observed from day 2

Results 2

Irritation parameter:

edema score

Remarks:

(for 3 minute-exposure)

Basis:

animal #1

Time point:

other: mean of the 24, 48 and 72-hour readings

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 13 days

Irritant / corrosive response data:

A very slight erythema (grade 1) was recorded 1 hour after removal of the dressing, then a severe erythema (grade 4), a severe oedema (grade 4) and cutaneous necrosis were noted from day 2 up to day 5. Necrosis was replaced by crusts which have masked cutaneous reactions between days 6 to 9. A well-defined erythema (grade 2) and dryness of the skin were then noted up to day 15 and a slight oedema (grade 2) was recorded up to day 12.
( Raw results: see tables 1 and 2 in results and discussion free-text)

Other effects:

no

Any other information on results incl. tables

Table 1: Individual cutaneous examinations and mean values of the scores recorded at each reading (24, 48 and 72 hours) for the animal

Rabbit number	Dermal Irritation	Scores				Mean irritation score (1)	Interpretation (+) (-)
		1 h D1	24h D2	48h D3	72h D4
01	Erythema	1	4	4	4	4.0	(+)
	Oedema	0	4	4	4	4.0	(+)
	Other		N	N	N

(1) mean of scores on days 2, 3 and 4

h — hour

D - day

(+) — irritant according to E.E.C. criteria

(-) — non-irritant according to E.E.C. criteria * — None

N — Necrosis

Table 2: Individual cutaneous examinations and mean values of the scores recorded at each reading for day 5 to day 15 for the animal

Rabbit number

Dermal Irritation

Scores

D5

D6

D7

DS

D9

D10

D11

D12

D13

D14

D15

01

Erythema

4

LA

LA

LA

LA

2

2

2

2

2

2

Oedema

4

LA

LA

LA

LA

2

2

2

0

0

0

Other

N

A

A

A

A

A/S

A/S

A/S

A/S

A/S

A/S

D: day

S: Dryness of the skin

N: Necrosis

A: Crusts

LA: Scoring masked by the crusts

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP (Reg. 1272/2008/EC) and Directive 67/548/EEC

Conclusions:

Under the experimental conditions of this study and according to the criteria laid down in CLP (Reg 1272/2008/EC) and directive 67/548/EEC, the test item is classified Corrosive Category 1A and Corrosive R35 respectively.

Executive summary:

The potential of the test item to induce skin irritation was assessed in rabbits according to the OECD (n°404, 17th july 1992) and Commission Regulation (EC) (n°92/69/E.E.C., B.4, 31st july 1992) guidelines. The study was performed in compliance with the principle of Good Laboratory Practices regulations.

As possible irritant effects were anticipated, the test item was evaluated in one animal in a first assay . 0.5 mL of the of the undiluted test item were applied in a first assay for a period of 3 minutes to the closely-clipped skin of one flank of one male New Zealand White rabbit. As the test substance showed corrosive properties in the first assay, the study was considered complete and it was not evaluated on other animals. The test substance was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until the end of the observation period. The mean values of the scores for erythema and oedema were calculated for the animal.

A very slight erythema was recorded one hour after removal of the dressing, then a severe erythema, a severe oedema and cutaneous necrosis were noted from day 2 up to day 5. Necrosis was replaced by crusts which have masked cutaneous reactions between day 6 to day 9. A well-defined erythema and dryness of the skin were then noted up to day 15 and a slight oedema was recorded up to day 12. Mean scores over 24, 48 and 72 hours for the animal were 4.0 for erythema and 4.0 for oedema.

Under these experimental conditions, the test substance was considered to be corrosive to the rabbit skin.